Kornimate/medical-research-clean huggingface dataset:
prognostic value of residual hypoventilation in mechanically ventilated neuromuscular patients

Conditions: Home Mechanical Ventilation; Neuromuscular Disease

Summary: different tools may be used to monitor the efficacy of home mechanical ventilation. investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

home mechanical ventilation (hmv) is used to treat hypoventilation, and its efficacy is mostly assessed by daytime blood gases and nocturnal oxymetry (spo2). transcutaneous co2 measure (tcco2) has shown higher sensitivity than spo2 to detect hypoventilation in neuromuscular diseases (nmd) patients. no data exist on the prognostic value of these techniques to monitor mechanical ventilated nmd patients. basing on retrospective data review, investigators aimed to compare the prognostic value of the data obtained using different tools to assess residual hypoventilation in the cohort of ventilated nmd patients followed at our reference center.

Eligibility criteria:
inclusion criteria: * neuromuscular disease * age ≥18 years * mechanically ventilated * capno-oxymetry performed between 2009 and 2011 exclusion criteria: * long-term oxygen therapy

Keywords: nocturnal hypoventilation capno-oxymetry
protective effects of l-arginine during reperfusion by femoropopliteal bypass for lower limb ischemic syndrome in humans

Conditions: Skeletal Muscle Ischemia; Severe Lower Limb Ischemia; Mitochondrial Dysfunction

Summary: the symptoms and severity of arterial disease is secondary to perfusion deficit. the specific alteration of the mitochondrial function of ischemic skeletal muscle plays an important role, and therapeutic enhancing mitochondrial function are associated with a clinical improvement with increase in the walking distance of the patient. in severe ischemia, reperfusion required is accompanied by a deleterious episode through a worsening of endothelial dysfunction (impaired pathway of nitric oxide (no)), majorant alteration of cellular energy and the hormonal and inflammatory responses. this is reperfusion syndrome, which can lead to grave consequences. our goal is to limit mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the no pathway by in situ addition of its precursor, l-arginine. our working hypothesis is that this cellular improvement will be accompanied by an increase in systolic pressure index and an improvement in the walking distance. method: this is a trial with direct individual benefit, comparative, randomized, prospective, single-center, double-blind, versus placebo.

2 groups of 30 patients with severe lower limb ischemia requiring femoropopliteal bypass revascularization participate in the study. the control group (placebo isoosmotic saline) will be compared to the treated group (femoral arterial infusion of 2 g l-arginine for 30 min). heart rate, blood pressure and body temperature will be monitored continuously. the gastrocnemius muscle is biopsied before and 30 minutes after revascularization to analyze mitochondrial respiration and its control. both femoral and brachial concomitant venous samples will judge the importance of muscle damage (lactate, muscle enzymes) and released mediators (cytokines, no and endothelin) on the local and general. main clinical implications: l-arginine supplementation in atherosclerotic patients requiring femoropopliteal bypass to limit the initial deleterious effects of reperfusion and improve their walking distance and therefore their quality of life. then extending this treatment to other patients with peripheral arterial disease.

Eligibility criteria:
inclusion criteria: * atherosclerotic patient with peripheral arterial disease stage 2-4 leriche and fontaine classification * requiring surgical revascularization by femoropopliteal bypass * above 18 years old exclusion criteria: * active infectious disease * severe heart disease * chronic renal insufficency * pregnant women * women of childbearing age and with no effective contraception for at least three months

Keywords: l-arginine
a follow-on safety study in subjects with crohn's disease who have previously been withdrawn from the double-blind study cdp870-031 [nct00152490] or cdp870-032 [nct00152425] due to an exacerbation of crohn's disease

Conditions: Crohn's Disease

Summary: a follow-on safety study in subjects with crohn's disease who have previously been withdrawn from the double-blind study cdp870-031 \[nct00152490\] or cdp870-032 \[nct00152425\] due to an exacerbation of crohn's disease.


Eligibility criteria:
inclusion criteria: * participation in either of the cdp870-031 \[nct00152490\] or cdp870-032 \[nct00152425\] clinical studies in which the subject completed the week 2 assessment in cdp870-031 \[nct00152490\] or the week 6 randomization in cdp870-032 \[nct00152425\] but whose crohn's disease was significantly worse as determined by the investigator and whose clinical disease activity index (cdai) score at entry to this study is either (subjects may have received active or placebo treatment): 1. at least 70 points higher then baseline (week 0 cdp870-031 \[nct00152490\]; week 6 cdp870 032 \[nct00152425\] responders) or 2. higher than baseline (week 0 cdp870-031 \[nct00152490\]; week 6 cdp870-032 \[nct00152425\] responders) with an absolute score of at least 350 points * subjects must be able to understand the information provided to them and give written informed consent exclusion criteria: * any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study (cdp870-031 \[nct00152490\] or cdp870-032 \[nct00152425\]), although the upper limit of 450 in the cdai score is not applicable. in addition the criterion that excludes previous participation in a clinical trial of certolizumab pegol does not apply
sodium fluoride imaging of abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this study is to determine whether sodium fluoride imaging (using positron emission tomography-computed tomography - pet-ct) is able to help predict the rate of abdominal aortic aneurysm expansion.

ruptured abdominal aortic aneurysms (aaas) have a 90% mortality rate but there are currently no accurate methods of establishing the risk of rupture for an individual patient with an asymptomatic aaa. in vascular disease, microcalcification occurs in response to necrotic inflammation. using computed tomography and positron emission tomography (pet-ct), early micro calcification can be identified using uptake of the radiotracer 18f-sodium fluoride. this can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. the study investigators therefore propose to evaluate the ability of 18f-sodium fluoride to identify regions of necrotic inflammation in aaa and predict aaa expansion. the study investigators will explore its value as part of an ongoing clinical trial assessing the identification of macrophage activity using magnetic resonance imaging - the ma3rs study (isrctn76413758). patients already enrolled in the ma3rs study will be recruited for the sofia3 study. control patients with a normal calibre aorta will be recruited from the national aaa screening programme.

Eligibility criteria:
inclusion criteria (aaa patients): * patients already enrolled in the ma3rs study (isrctn76413758) * patients with abdominal aortic aneurysm with ap diameter \>40 mm on ultrasound * \>50 years of age inclusion criteria (control patients): * patients with abdominal aorta with ap diameter \<30 mm on ultrasound * \>50 years of age exclusion criteria: * patients expected to undergo imminent aaa repair * patients who refuse or are unable to give informed consent * women of child-bearing potential without contraception * patients who are unable to undergo pet-ct scan * patients with collagen vascular disease * intercurrent illness, malignancy or comorbidity with life expectancy \<1 year * renal dysfunction (egfr \<30ml/min/1.73m2) * contraindication to pet-ct or cta * iodine allergy

Keywords: aortic aneurysm, abdominal sodium fluoride positron emission tomography
efficacy study of nivolumab compared to ipilimumab in prevention of recurrence of melanoma after complete resection of stage iiib/c or stage iv melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.


Eligibility criteria:
inclusion criteria: * at least 15 years of age except: where local regulations and/or institutional policies do not allow for subjects \< 18 years of age (pediatric population) to participate. for those sites, the eligible subject population is ≥ 18 years of age * completely removed melanoma by surgery performed within 12 weeks of randomization * stage iiib/c or stage iv before complete resection * no previous anti-cancer treatment exclusion criteria: * ocular or uveal melanoma * history of carcinomatosis meningitis * history of auto-immune disease * treatment directed against the resected melanoma that is administrated after the surgery other protocol-defined inclusion/exclusion criteria apply
intensive exercise to improve mitochondrial dysfunction in pediatric obesity

Conditions: Pediatric Obesity; Insulin Resistance; Mitochondrial Dysfunction

Summary: obesity and type 2 diabetes are occurring at epidemic rates in the united states and worldwide. the global burden of diabetes is estimated to double over the next 25 years. obese children are at risk for the development of insulin resistance, relative insulin deficiency and type 2 diabetes mellitus (dm). the prevention of type 2 dm is hindered by the lack of a non-invasive predictive test, knowledge as to individual risk and effective preventative measures. there is increasing evidence that alterations in mitochondria contribute to the development of diabetes in humans. therefore, it is important to explore mitochondrial dysfunction as a potential predictor of diabetes in children and a potential target for prevention. the aims of the proposed protocol are to determine whether an intensive exercise intervention can improve mitochondrial function in children identified as having mitochondrial dysfunction and insulin resistance. the use of a non-invasive imaging technique will allow for a functional in vivo assessment of mitochondrial activity. the investigators propose the investigation of an intensive exercise protocol designed to improve mitochondrial function in children who are insulin resistant and have documented mitochondrial dysfunction by magnetic resonance spectroscopy. the study is designed to investigate the plasticity of abnormal mitochondrial function in high risk children. in summary, the proposed projects will investigate mitochondrial function as a non-invasive predictive marker for the development of insulin resistance and type 2 diabetes mellitus in children and attempt to modify mitochondrial function with an intensive exercise intervention. the study of mitochondrial dysfunction in children may both identify those at risk for disease and provide a molecular therapeutic target for prevention and treatment. the investigators hypothesize that children with insulin resistance and mitochondrial dysfunction who are randomized to intensive exercise versus standard lifestyle advice will show improvement in mitochondrial function and insulin sensitivity.


Eligibility criteria:
inclusion criteria: * girls and boys ages 10 to 18 years old * body mass index more than 95th percentile for age and gender * insulin resistance based on: * fasting parameters: fasting insulin level, homa ir * oral glucose tolerance testing * mitochondrial function \> 1 median for normal based on control cohort exclusion criteria: * underlying medical problem with potential to affect growth, pubertal development or glucose homeostasis * chronic medical therapy with glucocorticoids, growth hormone, estrogen, progesterone, testosterone, or other medications with the potential to alter growth, pubertal development or glucose homeostasis within the proceeding 6 months * personal history of dm * inability to have mri scan performed due to metal prosthesis or implant

Keywords: pediatric obesity insulin resistance diabetes mitochondria
aperto cvs pmcf study

Conditions: Dialysis; Complications; Central Vein Obstruction; Stenosis; Restenosis

Summary: prospective observational single arm study aimed to assess safety and effectiveness of aperto otw dcb in treating stenosis and restenosis of central veins in dialysis patients

the aperto cvs pmcf study is aimed to evaluate safety and effectiveness of treatment of central veins (re)stenosis in dialysis patients at short and mid-term follow up, after treatment with aperto otw dcb. primary endpoint will consist in evaluating the intervention free period for patients treated with aperto otw. aperto cvs pmcf study will also collect data for post-market clinical follow up (pmcf) in a ce mark device used according to intended use

Eligibility criteria:
inclusion criteria: * patients age \>18, no pregnant women, able to perform fup visits, life expectancy \> 12 months * dialysis patients undergoing endovascular angioplasty due to clinically symptomatic stenosis (de novo or restenosis) of the central veins with significant (\>50%) stenosis and diameter * the target lesion consists of one or more lesions with a target lesion length of less than or equal to 100 mm * the target blood vessel diameter of the target lesion is between 6.0 and 16.0 mm (in angiographic or ultrasound evaluation); * if there are other non-target lesions, then non-target lesions must be successfully cured with a not drug coated balloon before treating the target lesion; exclusion criteria: * patients with cvs observed and estimated as nonsignificant (\ 12 mm in diameter by visual estimation; * the patient is now participating in another clinical trial to evaluate drug or medical device; * patient enrolled for this trial before; * prenatal pregnancy test result for women of childbearing potential is non-negative, lactating woman; * patients, who underwent major surgical procedures (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study; * patients scheduled to undergo major surgery (eg, thoracotomy, craniotomy, etc.) within 30 days after enrolment; * central veins lesions have been already treated with dcb before * presence of a bare metal stent (bms) or stent graft or vascular access thrombosis in central veins * patients allergic or intolerant to paclitaxel, or contrast media; * patients whose life expectancy is less than 1 year * presence of thrombus in central veins * tumor compression * thoracic inlet syndrome * patients implanted with pacing or cardioverter devices with leads * any other central line within the target lesion * patients with any contraindications as mentioned in the instructions for use (ifu) of the investigational device

Keywords: drug coated balloon central veins stenosis percutaneous intervention
risk stratification of nodal ptcl

Conditions: Peripheral T-Cell Lymphoma, Not Otherwise Specified; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large Cell Lymphoma, ALK-negative

Summary: this study is to investigate the prognostic significance of enhanced international prognostic index (nccn-ipi) and post-treatment pet results in patients with newly diagnosed nodal peripheral t-cell lymphoma (ptcl), and establish a risk stratification model for nodal ptcl patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with nodal ptcls (ptcl, nos; angioimmunblastic t-cell lymphoma; anaplastic large cell lymphoma \[alcl\], anaplastic lymphoma kinase \[alk\]-negative) * patients diagnosed with between january 1, 2004 and april 30, 2016 * initially treated with curative intent * patients with standard 18f-fluorodeoxyglucose (fdg) pet or pet-ct data at the time of diagnosis and at the end of primary treatment exclusion criteria: * patients diagnosed with extranodal ptcls, including followings (extranodal nk/t-cell lymphoma, nasal type; enteropathy-associated t-cell lymphoma; hepatosplenic t-cell lymphoma; subcutaneous panniculitis-like t-cell lymphoma; ebv-positive t-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas) * patients with alcl-alk+ * patients who do not have 18f-fdg pet or pet-ct data either at diagnosis or at the end of treatment available for review
novel pi3k delta inhibitor tgr-1202, in combination with brentuximab vedotin for hodgkin's lymphoma patients

Conditions: Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of tgr-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hodgkin's lymphoma * relapsed or refractory after an autologous stem cell transplant (asct) or at least two prior multi-agent chemotherapy regimens in patients not candidates for asct * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * known hepatitis b virus, hepatitis c virus or hiv infection * autologous hematologic stem cell transplant within 3 months of study entry. patients who had prior allogeneic hematologic stem cell transplant are excluded

Keywords: hodgkin's
substance use risk and solution-focused approach

Conditions: Self Efficacy

Summary: although substance abuse is the subject of serious struggles on the basis of individuals and countries, its rate of spread cannot be stopped and it creates an agenda with new people added every day. substance addiction, which not only creates physiological problems in individuals, but also affects human health in every aspect with psychological and social problems, adversely affects the health status of individuals as well as their families and environments. the best way to get rid of addiction is to never start. therefore, our study focused on preventing addiction, not addiction. after applying the substance use tendency scale and self-control scale to university students, an intervention and control group will be formed. solution focused approach program will be applied to the intervention group. at the end of the program, post-tests will be applied to the intervention and control groups.

first of all, the substance use tendency scale (mdas) and personal information form will be applied to the nursing students of the faculty of health sciences, which consists of 750 people. a high score in any of the bcas subscales indicates a tendency towards addiction. after this, students with a tendency will be determined. after the power analysis is performed, the appropriate number of samples will be determined. finally, participants will be assigned to the intervention/control group by randomization. a substance use prevention psychoeducation program based on a solution-focused approach will be applied to the experimental group in 7 sessions for 6 weeks. no intervention will be made to the control group. at the end of psychoeducation, posttests will be collected from the experimental and control groups.

Eligibility criteria:
the criteria for inclusion in the research at the stage; * being an active student registered as a nursing student at fırat university * volunteering to participate in the research. * not receiving any psychological counseling and treatment * getting a sufficiently high score in any of the sub-dimensions according to the substance use risk profile scale * not being diagnosed with substance abuse or substance abuse exclusion criteria from the study at phase i; * not complying with the principle of volunteering * getting a low score in all sub-dimensions according to the substance use risk profile scale * being diagnosed with substance abuse or substance abuse

Keywords: substance use solution focused approach addiction tendency
safety and efficacy of at-527 in subjects with moderate coronavirus disease (covid-19) in a hospital setting

Conditions: COVID-19

Summary: the objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of at-527 in adult subjects ≥18 years of age with moderate covid-19 and risk factors for poor outcomes (such as obesity (bmi\>30), hypertension, diabetes or asthma). eligible subjects will be randomized to blinded at-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. part a will evaluate an at-527 dose of 550 mg bid and part b will evaluate a second dose of at-527 (1100 mg bid). local supportive standard of care (soc) will be allowed for all subjects. efficacy, antiviral activity and safety observations will be compared for treatment with active at-527 tablets vs. placebo tablets.


Eligibility criteria:
key inclusion criteria: * hospitalized or in a hospital-affiliated confinement facility * sars-cov-2 positive * initial covid-19 symptom onset within 5 days prior to screening * spo2 ≥ 93% on room air or requires ≤ 2l/min oxygen by nasal cannula or mask to maintain spo2 ≥ 93% * must also have a history of at least one of the following known risk factors for poor outcomes: obesity (bmi\>30), hypertension, diabetes or asthma. key exclusion criteria: * severe or critical covid-19 illness: rr ≥30, hr ≥125, spo2 \ 2l/min oxygen by nasal cannula or mask to maintain spo2 ≥93%, systolic blood pressure \< 90 mm hg, diastolic blood pressure \< 60 mm hg or pao2/fio2 \<300 * requires mechanical ventilation * lobar or segmental consolidation on chest imaging. * treatment with other drugs thought to possibly have activity against sars-cov-2 * alt or ast \> 5 x upper limit of normal (uln) * female subject is pregnant or breastfeeding * has received or is expected to receive any dose of a sars-cov-2 vaccine before the day 14 visit (part b).
study on yangxue nao granules reducing the risk of stroke

Conditions: Cerebral Infarction

Summary: objective: to explore the effectiveness of raising serum nao granules in reducing the risk of bleeding in patients with acute ischemic stroke treated with intravenous thrombolysis in the real world

objective: to explore the effectiveness of raising serum nao granules in reducing the risk of bleeding in patients with acute ischemic stroke treated with intravenous thrombolysis in the real world study design. this study was a single center real world study. through the review data, this study included in january 1, 2017 to september 30, 2019, see a doctor at peking university third hospital neurology, emergency diagnosis of acute ischemic stroke, and venous thrombolysis in patients with a queue, on the basis of whether the application have serum brain particles are divided into a group and the control group, serum application parameters and nonparametric comparison, k-m curve and cox regression model were used to evaluate the effectiveness of yangxuenao granules in reducing bleeding conversion after intravenous thrombolysis by comparing the number of microbleeding, stroke severity score and modified rankin score after 3 months follow-up with the weighted craniocerebral magnetic sensitivity imaging sequence reexamined within 48 hours.

Eligibility criteria:
inclusion criteria: * a cohort of patients admitted to the department of emergency neurology at peking university third hospital on january 1, 2017 and admitted on september 30, 2019, who were diagnosed with acute ischemic stroke and underwent intravenous thrombolysis. exclusion criteria: * patients who underwent intravenous thrombolysis but were confirmed to be apoplexy * like by imaging and other clinical examinations; incomplete craniocerebral mri examination; * bridging endovascular therapy; * the previous application of yangxuenao granules or other drugs with similar effects;